Can a Triple-Action therapy tackle stomach Cancer's spread?
NCT ID NCT07784413
First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time
Summary
This phase II trial is testing whether a combination of low-dose radiation, an immunotherapy drug (serplulimab), and chemotherapy can help people with stomach cancer that has spread to the lining of the abdomen (peritoneal metastasis). The study enrolls adults with HER2-negative gastric cancer who have already tried one line of treatment. Participants receive either irinotecan or albumin-bound paclitaxel along with serplulimab, plus an intraperitoneal infusion of a bevacizumab analog, after low-dose radiation. The goal is to see if this approach can shrink tumors and delay progression, while also assessing safety and tolerability.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- low-dose radiotherapy combined with serplulimab, bevacizumab analog, and irinotecan or albumin-bound paclitaxel
- What this could lead to
- If successful, this combination could offer a new treatment option for gastric cancer that has spread to the lining of the abdomen, potentially extending survival and improving quality of life.
- What could go wrong
- This is an early-phase trial with a small number of patients, so results may not be conclusive. The combination of treatments may cause significant side effects, and the benefit may not be confirmed in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Age \>18 years on the day of signing the Informed Consent Form; 2. The subject is able to comprehend the procedures and methods of this clinical study, and voluntarily signs the informed consent form after providing full informed consent. 3\. Gastric or gastroesophageal junction adenocarcinoma (HER2-negative) confirmed by histology or cytology. 4\. Imaging confirmed metastases to peritoneum (PCI score ≥10), not suitable for radical excision 5. Failure of first-line platinum-based chemotherapy (due to progression or inability to tolerate). 6\. CT imaging or PET CT suggests metastases to the peritoneum, or ascites cytology is positive. 7\. ECOG PS 0-2, expected survival ≥3 months. 8. Organ function meets the following criteria (within 10 days of first receiving the investigational medicinal product). 1. Hematology: Platelet count ≥100×10⁹/L, hemoglobin ≥8g/dL, ANC ≥1.5×10⁹/L, and no blood products, erythropoiesis-stimulating agents, or colony-stimulating factors therapy received within the past 7 days; 2. Renal function: Serum creatinine is within the normal upper limit range set by the institution; 3. Liver function: Total bilirubin ≤ 1.5×UNL; if total bilirubin \> 1.5×UNL, then direct bilirubin should be ≤ UNL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤ 2.5×UNL, albumin \> 2.5 mg/dL; 4. Coagulation function: International normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (APTT) ≤1.5×UNL; if the subject is undergoing anticoagulation therapy, it should be within the established therapeutic range; 9. Women of childbearing age must have a negative serum pregnancy test within 72 hours prior to the first administration of the investigational medicinal product. If the urine test result is positive or cannot be confirmed as negative, further serum pregnancy testing is required. 10\. Women of childbearing age must agree to use two effective methods of birth control or undergo surgical sterilization, or choose to avoid any heterosexual intercourse throughout the study period and for 120 days after the last drug administration. (Women who have been postmenopausal for more than one year and have not undergone surgical sterilization are considered infertile.) Lactating women must cease breastfeeding. 11\. Male subjects should agree to adopt effective contraceptive measures from the first administration until 120 days after the final administration. Exclusion Criteria: * 1\. Presence of active metastases to the central nervous system or meningitis carcinomatosa. 2\. There is an uncontrolled abdominal infection, intestinal obstruction, grade 3 abdominal effusion, or risk of gastrointestinal fistula and perforation. 3\. Study participants received systemic immunosuppressant therapy within 28 days prior to treatment. 4\. Known to be allergic to any investigational product or any excipient of the investigational product. 5\. Diagnosed with other malignancies within the past 5 years, and the tumor is currently in a progressive stage or requires therapy (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical carcinoma in situ that has undergone potential radical treatment). 6\. There is active autoimmune disease, and systemic therapy (including the use of disease-modifying drugs, corticosteroids, or immunosuppressants) has been received in the past two years. Replacement therapy (e.g., thyroxine replacement for hypothyroidism, insulin therapy for diabetes, or physiological glucocorticoid supplementation for adrenal/pituitary insufficiency) is not considered systemic therapy. 7\. Previously suffered from (non-infectious) pneumonia requiring glucocorticoid therapy, or currently suffering from pneumonia. 8\. There is an active infection requiring systemic therapy. 9. The presence of any history of disease, therapy, or laboratory abnormalities that could potentially interfere with the test results, affect the subject's full participation, or be deemed unsuitable for the subject's participation in the study by the Sub investigator. 10\. Past or current presence of mental disease or drug abuse, deemed by the sub investigator as unable to comply with trial requirements. 11\. Already pregnant or in lactation, or plans to become pregnant or cause pregnancy during the trial period (from the start of pre-screening or screening visit to 120 days after the final administration). 12\. Known infection with Human Immunodeficiency Virus (HIV1/2 antibody positive). 13\. Known to have hepatitis B (e.g., HBV Hepatitis B Surface Antigen positive) or hepatitis C (e.g., HCV RNA test positive). 14\. Received any live vaccine within 30 days prior to the first use of the investigational medicinal product.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China